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FDA Advisers Consider New Lupus Drug
Date:11/16/2010

current treatments include chemotherapy and steroids, which can leave the door open to infections, cancers and other unwanted consequences, Raymond said.

Dr. Joan Merrill, head of Clinical Pharmacology at the Oklahoma Medical Research Foundation and medical director of the Lupus Foundation of America, added that "the safety data on Benlysta looks better than we usually see with biologics."

"We have to keep in mind that there is a natural ceiling on the percentage of patients who can respond to any targeted treatment. We do not yet know exactly how good Benlysta is," Merrill said.

What is known is that Benlysta was shown to be statistically superior to a placebo in two phase 3 trials, she said.

"I hope that the FDA will be able to approve it, after they complete the serious deliberations that they must make on all the data," Merrill said.

Lupus is an autoimmune disease in which the body produces antibodies that attack and destroy healthy tissue. This can damage joints, skin, blood vessels and organs. Benlysta works by inhibiting the production of these antibodies.

Benlysta is made by Human Genome Sciences and GlaxoSmithKline.

While the FDA is not bound by its advisory committees' recommendations it usually does so.

More information

To learn more about lupus, visit the Lupus Foundation of America.

SOURCES: Sandra C. Raymond, President & CEO, Lupus Foundation of America; Joan Merrill, M.D., head, Clinical Pharmacology, Oklahoma Medical Research Foundation, Medical Director, Lupus Foundation of America


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